1st Edition

Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries

By R. Baird, Sally F. Bloomfield Copyright 1996

    The importance of quality assurance in the production, storage and use of manufactured preparations is widely recognized. This book encapsulates the issues involved in the manufacture of non-steriles, such as creams, ointments, herbal remedies, shampoos, soaps and toiletry products (as opposed to sterile drugs and injectible products). Knowledge of the microbial limits is expanded, new standards are included, and coverage of the preservation issues of dosage forms is widened to include semi-solids and liquid preparations. This edition also contains new regulations regarding preservative efficacy testing and covers pharmacopoeial and industry regulations and guidelines. Rapid methods are also discussed, now more common in cosmetic and toiletry practice, in their pharmaceutical capacity.

    Part 1 Identifying the issues: control of microbial contamination in cosmetics, toiletries and non-sterile pharmaceuticals; hazards associated with the microbiological contamination of cosmetics, toiletries and pharmaceuticals. Part 2 Control in manufacture: microbiological control of raw materials; control of microbial contamination during manufacture. Part 3 Control through preservation: natural and physical preservative systems; the effect of container materials and multiple phase formulation components on the activity of antimicrobial agents; formulation aspects of the preservation of skin and hair products; preservation of solid oral dosage forms; development of preservative systems; microbial resistance to preservative systems; safety evaluation of preservatives. Part 4 Microbiological control - methods and standards: preservative efficacy testing of pharmaceuticals, cosmetics and toiletries and its limitations; challenge tests and their predictive ability; new methodology for microbial quality assurance; microbial contamination of manufactured products - official and unofficial limits.


    Baird, R.; Bloomfield, Sally F.